Mupirocin cream 2% (available as Bactroban® cream) is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes). Mupirocin is an antibiotic. It works by stopping the growth of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes).
Nowadays antimicrobial resistance has been described as a “crisis for the health and wealth of nations”. One of the key strategies to mitigate this public health crisis is to ensure that existing antimicrobials are used responsibly and judiciously. The article “A bug in the ointment: topical antimicrobial usage and resistance in New Zealand” published by New Zealand Medical Association in journal NZMJ, 4 Dec. 2015, Vol 128; No 1426, discloses the threat of antimicrobial resistance from mupirocin.
U.S. Pat. No. 6,025,389 discloses a pharmaceutical composition comprising a cream base and a therapeutic agent, such as mupirocin, and a method for treating a bacterial infection using the composition. WO 2008/007182 discloses a topical pharmaceutical composition comprising (a) a therapeutically effective amount of mupirocin or a pharmaceutically acceptable salt or ester thereof and (b) one or more esters of a fatty acid. U.S. Pat. No. 6,025,389 and WO 2008/007182 are silent on the drawbacks associated with dispensing of mupirocin cream.
The dispensers known in art such as aluminium tubes are generally simple and convenient to use, but the amount of drug dispensed cannot be precisely controlling resulting in significant waste. There are several other disadvantages associated with providing mupirocin cream to a patient in an aluminium tube. Aluminium tubes pre-filled with a topical mupirocin cream are, for example, messy, difficult and clumsy to use, and more importantly imprecise. These known drawbacks can lead to needless product waste, overdosing, inadequate dosing, failed compliance, passive (unintended) transfer to other areas of the patients' bodies, such as the eyes, ears, nose and mouth. All of these may result in antimicrobial resistance from mupirocin against Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes). Over-application of medication increases the potential for application-site reactions and signs and symptoms of skin irritation, at least in some patients. Thus, dosing inconsistencies and product waste associated with aluminium tubes of mupirocin are problematic, common and a cause for concern.
In yet another drawback, aluminium tubes can be very difficult and cumbersome to use, especially when elderly patients are involved. Opening the aluminium tube and dispensing the cream to “only” a targeted area without excessive handling or passive transfer can be a challenge to those patients inflicted with limited dexterity, crippling arthritis, vision loss or visual acuity loss, which are commonly observed in elderly patients.
In still another drawback associated with aluminium tubes, mupirocin cream degradants may develop over time as a result of storage in an aluminium tube. This drawback may cause an adverse effect on overall efficacy and/or stability of the mupirocin cream formulations packaged within aluminium tube. Thus, there is an unmet need for a simple, safe, clean, easy-to-use, compact, reliable system for dispensing topical mupirocin cream.